U.S. patent application number 11/250310 was filed with the patent office on 2007-04-19 for child resistant and senior friendly medicament storage and distribution package.
This patent application is currently assigned to R.P. Scherer Technologies, Inc.. Invention is credited to David Barndt, Tim Craig, Victor Gherdan.
Application Number | 20070084747 11/250310 |
Document ID | / |
Family ID | 37947154 |
Filed Date | 2007-04-19 |
United States Patent
Application |
20070084747 |
Kind Code |
A1 |
Gherdan; Victor ; et
al. |
April 19, 2007 |
Child resistant and senior friendly medicament storage and
distribution package
Abstract
A child resistant senior friendly medication storage and
distribution package including a blister portion and a blocking
substrate sandwiched between a dispensing substrate and a backing
substrate. The procedure to access the medicament is easy for an
adult to understand and accomplish, yet difficult for most
children. The blister portion contains a base layer and a blister
layer. The blister layer includes an article receiving blister
designed for holding the medicament. The dispensing substrate has a
dispensing substrate blister receiver. The blister receiver is
configured to cooperate with the blister so it extends through the
dispensing substrate. The blocking substrate includes a gate that
initially covers a portion of the blister. The gate must be moved,
or slid, out of the way in order to eject the medicament. The user
applies a force to the gate causing it to translate between the
backing substrate and the dispensing substrate.
Inventors: |
Gherdan; Victor; (Cherry
Hill, NJ) ; Barndt; David; (Richlandtown, PA)
; Craig; Tim; (Bensalem, PA) |
Correspondence
Address: |
CARDINAL HEALTH
7000 CARDINAL PLACE
LEGAL DEPARTMENT - INTELLECTUAL PROPERTY
DUBLIN
OH
43017
US
|
Assignee: |
R.P. Scherer Technologies,
Inc.
|
Family ID: |
37947154 |
Appl. No.: |
11/250310 |
Filed: |
October 14, 2005 |
Current U.S.
Class: |
206/531 |
Current CPC
Class: |
B65D 2575/363 20130101;
B65D 2215/04 20130101; B65D 83/0463 20130101 |
Class at
Publication: |
206/531 |
International
Class: |
B65D 83/04 20060101
B65D083/04 |
Claims
1. A medicament storage and distribution package (10) for housing a
medicament (M), comprising: (a) a blister portion (100) having: (i)
a base layer (110) having a base layer perimeter (120), a base
layer exterior surface (130), and a base layer interior surface
(140); (ii) a blister layer (150) having a blister layer perimeter
(160), a blister layer exterior surface (170), a blister layer
interior surface (180), and including an article receiving blister
(190), having a blister perimeter (196), formed therein, wherein
the article receiving blister (190) is designed for holding the
medicament (M); wherein (iii) at least five percent of the surface
area of the base layer interior surface (130) is joined to the
blister layer interior surface (180) thereby sealing the medicament
(M) in the article receiving blister (190); (b) a dispensing
substrate (200) having a dispensing substrate perimeter (201), a
dispensing substrate interior surface (210), and a dispensing
substrate exterior surface (220), wherein the dispensing substrate
(200) is formed to have: (i) a dispensing substrate blister
receiver (230) configured to cooperate with the blister portion
(100) such that a portion of the article receiving blister (190)
extends through the dispensing substrate (200) from the dispensing
substrate interior surface (210) to the dispensing substrate
exterior surface (220); and (ii) a dispensing substrate initiation
region (240); (c) a blocking substrate (300) having a blocking
substrate perimeter (301), a blocking substrate front surface
(310), and a blocking substrate rear surface (320), wherein the
blocking substrate (300) includes a gate (340) having a gate
perimeter (342) including a gate free edge (343) and a gate
retaining edge (348); (d) a backing substrate (400) having a
backing substrate perimeter (401), a backing substrate interior
surface (410), and a backing substrate exterior surface (420),
wherein the backing substrate (400) is formed to have: (i) a
backing substrate initiation region (430); and (ii) an article
dispensing region (440) having an article dispensing region
perimeter (442), wherein the article dispensing region (440) is
configured to cooperate with the blister portion (100); and (e)
wherein the blister portion blister layer (150) is adjacent to the
dispensing substrate interior surface (210), the blocking substrate
front surface (310) is adjacent to the blister portion base layer
(110), and the backing substrate interior surface (410) is adjacent
to the blocking substrate rear surface (320) such that the
dispensing substrate blister receiver (230), the article receiving
blister (190), and the article dispensing region (440)
substantially align, and the gate (340) is initially located
between the article dispensing region (440) and the article
receiving blister (190) to prevent unintentional dispensing of the
medicament (M), such that dispensing of the medicament (M) requires
application of a first force to a portion of the gate (340)
resulting in the gate free edge (343) sliding toward the gate
retaining edge (348) and past the article dispensing region (440)
such that application of a second force to the article receiving
blister (190) forces the medicament (M) to break through the base
layer (110), pass through an opening in the blocking substrate
(300) created by the movement of the gate (340), and out the
article dispensing region (440).
2. The child resistant medicament storage and distribution package
(10) of claim 1, wherein the gate (340) has a fold promoting
characteristic (350) that causes the gate (340) to begin to fold
about the fold promoting characteristic (350) when the gate (340)
is displaced out of the plane of the package (10) by the first
force, thereby creating a pivot projection (352) that is easily
pivoted about the gate retaining edge (348) and away from the
article receiving blister (190) drawing the gate free edge (343)
past the article receiving blister (190) to permit dispensing of
the medicament (M).
3. The child resistant medicament storage and distribution package
(10) of claim 1, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the dispensing substrate initiation region (240)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
4. The child resistant medicament storage and distribution package
(10) of claim 3, wherein the dispensing substrate initiation region
(240) defines a void formed in the dispensing substrate (200) sized
to cooperate with the gate (340) such that application of the first
force results in a portion of the gate (340) extending through the
dispensing substrate initiation region (240).
5. The child resistant medicament storage and distribution package
(10) of claim 3, wherein the dispensing substrate initiation region
(240) is an integral portion of the dispensing substrate (200) and
has a dispensing substrate initiation region perimeter (242), a
portion that is a dispensing substrate initiation region retaining
edge (244) that secures the dispensing substrate initiation region
(240) to the dispensing substrate (200) and serves as a line about
which the dispensing substrate initiation region (240) may pivot as
a portion of the gate (340) is forced through a void in the
dispensing substrate (200) previously occupied by the dispensing
substrate initiation region (240).
6. The child resistant medicament storage and distribution package
(10) of claim 5, wherein the dispensing substrate initiation region
perimeter (242) includes a portion of that is a dispensing
substrate initiation region breakaway edge (243) that initially
secures the dispensing substrate initiation region (240) to the
dispensing substrate (200) until the first force reaches a
predetermined magnitude causing the breakaway edge (243) to release
from the remainder of the dispensing substrate (200) and pivot
about the dispensing substrate initiation region retaining edge
(244), thereby allowing a portion of the gate (340) to pass a void
in the dispensing substrate (200) previously occupied by the
dispensing substrate initiation region (240).
7. The child resistant medicament storage and distribution package
(10) of claim 1, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the backing substrate initiation region (430)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
8. The child resistant medicament storage and distribution package
(10) of claim 7, wherein the backing substrate initiation region
(430) defines a void formed in the backing substrate (400) sized to
cooperate with the gate (340) such that application of the first
force results in a portion of the gate (340) extending through the
backing substrate initiation region (430).
9. The child resistant medicament storage and distribution package
(10) of claim 7, wherein the backing substrate initiation region
(430) is an integral portion of the backing substrate (400) and has
a backing substrate initiation region perimeter (432), a portion
that is a backing substrate initiation region retaining edge (434)
that secures the backing substrate initiation region (430) to the
backing substrate (400) and serves as a line about which the
backing substrate initiation region (430) may pivot as a portion of
the gate (340) is forced through a void in the backing substrate
(400) previously occupied by the backing substrate initiation
region (430).
10. The child resistant medicament storage and distribution package
(10) of claim 9, wherein the backing substrate initiation region
perimeter (432) includes a portion of that is a backing substrate
initiation region breakaway edge (433) that initially secures the
backing substrate initiation region (430) to the backing substrate
(400) until the first force reaches a predetermined magnitude
causing the breakaway edge (433) to release from the remainder of
the backing substrate (400) and pivot about the backing substrate
initiation region retaining edge (434), thereby allowing a portion
of the gate (340) to pass a void in the backing substrate (400)
previously occupied by the backing substrate initiation region
(430).
11. The child resistant medicament storage and distribution package
(10) of claim 1, wherein the backing substrate article dispensing
region (440) defines a void formed in the backing substrate (400)
sized to cooperate with the medicament (M) so that the medicament
(M) may pass through the article dispensing region (440) for
distribution.
12. The child resistant medicament storage and distribution package
(10) of claim 1, wherein the backing substrate article dispensing
region (440) is an integral portion of the backing substrate (400)
having a separation line (444) selectively reducing the strength of
the backing substrate (400), thereby permitting the medicament (M)
to break a portion of the article dispensing region (440) free of
the backing substrate (400) along the separation line (444) when
the medicament (M) is exposed to the second force, thereby
permitting the medicament (M) to pass through the article
dispensing region (440) for distribution.
13. The child resistant medicament storage and distribution package
(10) of claim 12, wherein the separation line (444) is located
substantially on the article dispensing region perimeter (442).
14. The child resistant medicament storage and distribution package
(10) of claim 13, wherein the separation line (444) comprises one
or more of the group consisting of die cuts, perforations,
indentations, score lines, and weakened fracture lines.
15. The child resistant medicament storage and distribution package
(10) of claim 1, wherein the blocking substrate (300) and the
backing substrate (400) are comprised of a material and thickness
that cannot be readily ruptured by a human finger pushing on the
medicament (M) in the article receiving blister (190).
16. The child resistant medicament storage and distribution package
(10) of claim 1, wherein the dispensing substrate initiation region
(240) and the backing substrate initiation region (430) are sized
to cooperate with the dimensions of a tip of a human finger.
17. The child resistant medicament storage and distribution package
(10) of claim 16, wherein the dispensing substrate initiation
region (240) and the backing substrate initiation region (430) are
between approximately 0.12 square inches and approximately 0.5
square inches.
18. A child resistant medicament storage and distribution package
(10) for housing a medicament (M), comprising: (a) a blister
portion (100) having: (i) a base layer (110) having a base layer
perimeter (120), a base layer exterior surface (130), and a base
layer interior surface (140); (ii) a blister layer (150) having a
blister layer perimeter (160), a blister layer exterior surface
(170), a blister layer interior surface (180), and including an
article receiving blister (190), having a blister perimeter (196),
formed therein, wherein the article receiving blister (190) is
designed for holding the medicament (M); wherein (iii) at least
five percent of the surface area of the base layer interior surface
(130) is joined to the blister layer interior surface (180) thereby
sealing the medicament (M) in the article receiving blister (190);
(b) a dispensing substrate (200) having a dispensing substrate
perimeter (201), a dispensing substrate interior surface (210), and
a dispensing substrate exterior surface (220), wherein the
dispensing substrate (200) is formed to have: (i) a dispensing
substrate blister receiver (230) configured to cooperate with the
blister portion (100) such that a portion of the article receiving
blister (190) extends through the dispensing substrate (200) from
the dispensing substrate interior surface (210) to the dispensing
substrate exterior surface (220); and (ii) a dispensing substrate
initiation region (240) integral to the dispensing substrate (200)
and having a dispensing substrate initiation region perimeter (242)
with (a) a portion that is a dispensing substrate initiation region
retaining edge (244) that secures the dispensing substrate
initiation region (240) to the dispensing substrate (200) and
serves as a line about which the dispensing substrate initiation
region (240) may pivot, and (b) a portion that is a dispensing
substrate initiation region breakaway edge (243) that initially
secures the dispensing substrate initiation region (240) to the
dispensing substrate (200) until acted upon by a force of a
predetermined magnitude that causes the breakaway edge (243) to
release from the remainder of the dispensing substrate (200); (c) a
blocking substrate (300) having a blocking substrate perimeter
(301), a blocking substrate front surface (310), and a blocking
substrate rear surface (320), wherein the blocking substrate (300)
includes a gate (340) having a gate perimeter (342) including a
gate free edge (343) and a gate retaining edge (348); (d) a backing
substrate (400) having a backing substrate perimeter (401), a
backing substrate interior surface (410), and a backing substrate
exterior surface (420), wherein the backing substrate (400) is
formed to have: (i) a backing substrate initiation region (430)
integral to the backing substrate (400) and having a backing
substrate initiation region perimeter (432) with (a) a portion that
is a backing substrate initiation region retaining edge (434) that
secures the backing substrate initiation region (430) to the
backing substrate (400) and serves as a line about which the
backing substrate initiation region (430) may pivot, and (b) a
portion that is a backing substrate initiation region breakaway
edge (433) that initially secures the backing substrate initiation
region (430) to the backing substrate (400) until acted upon by a
force of a predetermined magnitude causing the breakaway edge (433)
to release from the remainder of the backing substrate (400); and
(ii) an article dispensing region (440) having an article
dispensing region perimeter (442), wherein the article dispensing
region (440) is configured to cooperate with the blister portion
(100); and (e) wherein the blister portion blister layer (150) is
adjacent to the dispensing substrate interior surface (210), the
blocking substrate front surface (310) is adjacent to the blister
portion base layer (110), and the backing substrate interior
surface (410) is adjacent to the blocking substrate rear surface
(320) such that the dispensing substrate blister receiver (230),
the article receiving blister (190), and the article dispensing
region (440) substantially align, and the gate (340) is initially
located between the article dispensing region (440) and the article
receiving blister (190) to prevent unintentional dispensing of the
medicament (M), such that dispensing of the medicament (M) requires
application of a first force to a portion of the gate (340)
resulting in the gate free edge (343) sliding toward the gate
retaining edge (348) and past the article dispensing region (440)
such that application of a second force to the article receiving
blister (190) forces the medicament (M) to break through the base
layer (110), pass through an opening in the blocking substrate
(300) created by the movement of the gate (340), and out the
article dispensing region (440).
19. The child resistant medicament storage and distribution package
(10) of claim 18, wherein the gate (340) has a fold promoting
characteristic (350) that causes the gate (340) to begin to fold
about the fold promoting characteristic (350) when the gate (340)
is displaced out of the plane of the package (10) by the first
force, thereby creating a pivot projection (352) that is easily
pivoted about the gate retaining edge (348) and away from the
article receiving blister (190) drawing the gate free edge (343)
past the article receiving blister (190) to permit dispensing of
the medicament (M).
20. The child resistant medicament storage and distribution package
(10) of claim 18, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the dispensing substrate initiation region (240)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
21. The child resistant medicament storage and distribution package
(10) of claim 18, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the backing substrate initiation region (430)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
22. The child resistant medicament storage and distribution package
(10) of claim 18, wherein the backing substrate article dispensing
region (440) defines a void formed in the backing substrate (400)
sized to cooperate with the medicament (M) so that the medicament
(M) may pass through the article dispensing region (440) for
distribution.
23. The child resistant medicament storage and distribution package
(10) of claim 18, wherein the backing substrate article dispensing
region (440) is an integral portion of the backing substrate (400)
having a separation line (444) selectively reducing the strength of
the backing substrate (400), thereby permitting the medicament (M)
to break a portion of the article dispensing region (440) free of
the backing substrate (400) along the separation line (444) when
the medicament (M) is exposed to the second force, thereby
permitting the medicament (M) to pass through the article
dispensing region (440) for distribution.
24. The child resistant medicament storage and distribution package
(10) of claim 23, wherein the separation line (444) is located
substantially on the article dispensing region perimeter (442).
25. The child resistant medicament storage and distribution package
(10) of claim 18, wherein the blocking substrate (300) and the
backing substrate (400) are comprised of a material and thickness
that cannot be readily ruptured by a human finger pushing on the
medicament (M) in the article receiving blister (190).
26. The child resistant medicament storage and distribution package
(10) of claim 18, wherein the dispensing substrate initiation
region (240) and the backing substrate initiation region (430) are
sized to cooperate with the dimensions of a tip of a human
finger.
27. The child resistant medicament storage and distribution package
(10) of claim 26, wherein the dispensing substrate initiation
region (240) and the backing substrate initiation region (430) are
between approximately 0.12 square inches and approximately 0.5
square inches.
28. A medicament storage and distribution package (10) for housing
a medicament (M), comprising: (a) a blister portion (100) having:
(i) a base layer (110) having a base layer perimeter (120), a base
layer exterior surface (130), and a base layer interior surface
(140); (ii) a blister layer (150) having a blister layer perimeter
(160), a blister layer exterior surface (170), a blister layer
interior surface (180), and including an article receiving blister
(190), having a blister perimeter (196), formed therein, wherein
the article receiving blister (190) is designed for holding the
medicament (M); wherein (iii) at least five percent of the surface
area of the base layer interior surface (130) is joined to the
blister layer interior surface (180) thereby sealing the medicament
(M) in the article receiving blister (190); (b) a dispensing
substrate (200) having a dispensing substrate perimeter (201), a
dispensing substrate interior surface (210), and a dispensing
substrate exterior surface (220), wherein the dispensing substrate
(200) is formed to have: (i) a dispensing substrate blister
receiver (230) configured to cooperate with the blister portion
(100) such that a portion of the article receiving blister (190)
extends through the dispensing substrate (200) from the dispensing
substrate interior surface (210) to the dispensing substrate
exterior surface (220); and (ii) a dispensing substrate initiation
region (240), sized to cooperate with the dimensions of a tip of a
human finger, integral to the dispensing substrate (200) and having
a dispensing substrate initiation region perimeter (242) with (a) a
portion that is a dispensing substrate initiation region retaining
edge (244) that secures the dispensing substrate initiation region
(240) to the dispensing substrate (200) and serves as a line about
which the dispensing substrate initiation region (240) may pivot,
and (b) a portion that is a dispensing substrate initiation region
breakaway edge (243) that initially secures the dispensing
substrate initiation region (240) to the dispensing substrate (200)
until acted upon by a force of a predetermined magnitude that
causes the breakaway edge (243) to release from the remainder of
the dispensing substrate (200); (c) a blocking substrate (300)
having a blocking substrate perimeter (301), a blocking substrate
front surface (310), and a blocking substrate rear surface (320),
wherein the blocking substrate (300) includes a gate (340) having a
gate perimeter (342) including a gate free edge (343) and a gate
retaining edge (348), wherein the gate (340) has a fold promoting
characteristic (350) that causes the gate (340) to begin to fold
about the fold promoting characteristic (350) when the gate (340)
is displaced out of the plane of the package (10) by the first
force, thereby creating a pivot projection (352) that is easily
pivoted about the gate retaining edge (348) and away from the
article receiving blister (190) drawing the gate free edge (343)
past the article receiving blister (190) to permit dispensing of
the medicament (M); (d) a backing substrate (400) having a backing
substrate perimeter (401), a backing substrate interior surface
(410), and a backing substrate exterior surface (420), wherein the
backing substrate (400) is formed to have: (i) a backing substrate
initiation region (430), sized to cooperate with the dimensions of
a tip of a human finger, integral to the backing substrate (400)
and having a backing substrate initiation region perimeter (432)
with (a) a portion that is a backing substrate initiation region
retaining edge (434) that secures the backing substrate initiation
region (430) to the backing substrate (400) and serves as a line
about which the backing substrate initiation region (430) may
pivot, and (b) a portion that is a backing substrate initiation
region breakaway edge (433) that initially secures the backing
substrate initiation region (430) to the backing substrate (400)
until acted upon by a force of a predetermined magnitude causing
the breakaway edge (433) to release from the remainder of the
backing substrate (400); and (ii) an article dispensing region
(440) having an article dispensing region perimeter (442), wherein
the article dispensing region (440) is configured to cooperate with
the blister portion (100) and the article dispensing region (440)
is an integral portion of the backing substrate (400) having a
separation line (444) located substantially on the article
dispensing region perimeter (442) to selectively reducing the
strength of the backing substrate (400), thereby permitting the
medicament (M) to break a portion of the article dispensing region
(440) free of the backing substrate (400) along the separation line
(444) when the medicament (M) is exposed to the second force,
thereby permitting the medicament (M) to pass through the article
dispensing region (440) for distribution; and (e) wherein the
blister portion blister layer (150) is adjacent to the dispensing
substrate interior surface (210), the blocking substrate front
surface (310) is adjacent to the blister portion base layer (110),
and the backing substrate interior surface (410) is adjacent to the
blocking substrate rear surface (320) such that the dispensing
substrate blister receiver (230), the article receiving blister
(190), and the article dispensing region (440) substantially align,
and the gate (340) is initially located between the article
dispensing region (440) and the article receiving blister (190) to
prevent unintentional dispensing of the medicament (M), such that
dispensing of the medicament (M) requires application of a first
force to a portion of the gate (340) resulting in the gate free
edge (343) sliding toward the gate retaining edge (348) and past
the article dispensing region (440) such that application of a
second force to the article receiving blister (190) forces the
medicament (M) to break through the base layer (110), pass through
an opening in the blocking substrate (300) created by the movement
of the gate (340), and out the article dispensing region (440).
29. The child resistant medicament storage and distribution package
(10) of claim 28, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the dispensing substrate initiation region (240)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
30. The child resistant medicament storage and distribution package
(10) of claim 28, wherein application of the first force to the
portion of the gate (340) results in a portion of the gate (340)
extending through the backing substrate initiation region (430)
resulting in movement of the gate free edge (343) such that the
gate (340) does not block access to the article dispensing region
(440).
31. The child resistant medicament storage and distribution package
(10) of claim 28, wherein the blocking substrate (300) and the
backing substrate (400) are comprised of a material and thickness
that cannot be readily ruptured by a human finger pushing on the
medicament (M) in the article receiving blister (190).
Description
TECHNICAL FIELD
[0001] The present invention generally relates to medication
packages and, more particularly, relates to child resistant and
senior friendly medication packages that incorporate a sliding gate
type component to control access to the dosage forms.
BACKGROUND OF THE INVENTION
[0002] There is a continued need for medication packages that are
child resistant and tamper evident, yet allow the average adult to
open the medication packages to get access to the medication
therein, as well as the adult who, due to either age or medical
infirmity, may have reduced motor skills. Such packaging has been
called "child resistant senior friendly." There is also a need to
make this type of package economical to manufacture.
[0003] Over the years, a wide variety of disposable medication
packages have been suggested which are accessible through a variety
of folding, stripping, rupturing, peeling, and/or tearing
procedures. These packages have typically been formed of
transparent top layers which are sealed or otherwise bonded to
backing layers in a manner which provides a cavity, pouch or
"blister" in which the medicament is disposed. The top and backing
layers may be formed of flexible packaging materials, rigid
thermoformable plastic materials, foil, paper, laminates, or
combinations thereof. Medicament cavities formed between such
layers have been accessed by tearing into them from an edge of the
package, which tearing may or may not be facilitated through the
provision of a starting notch or slit, or by simply pushing on the
blister until the medicament breaks through the backing layer.
Alternatively, these cavities may be accessed by stripping a
backing layer from the package to expose the cavity, or to expose a
push-through underlayer. In other instances, the backing layer is
made of foil that can be ruptured when the medication in the
blister is pushed against the backing layer. Generally, these
packages are tamper evident, but typically not child resistant.
Other medication packages require some form of peeling of the
bottom surface from the top surface to get access to the
medication. Some examples of these types of medication packages
that use peeling include U.S. Pat. No. RE29,705 (Compere); U.S.
Pat. No. 3,941,248 (Moser); U.S. Pat. No. 4,243,144 (Margulies);
U.S. Pat. No. 4,988,004 (Intini); U.S. Pat. No. 5,046,618 (Wood);
and U.S. Pat. No. 5,358,118 (Thompson).
[0004] Child resistant medication packages that use peeling have
been in use for some time, however, many people who do not have
sufficient motor skills or whose hands shake are not able to easily
gain access to the medicament in such packages. This can be a
problem especially when the medicament and the medication packages
are small. Additionally, there have been a number of medication
packages that are designed to be torn open to access the
medication. Many medication packages that are designed to be torn
suffer from the same problems as those designed for peeling, namely
they are difficult to open for those with reduced motor skills or
do not exhibit a high degree of child-resistance.
[0005] There is a need for a medication package that is relatively
easy to open for an adult, but still be child resistant. Further,
the package must be easy to manufacture without having to introduce
custom machinery, so that the package remains economical. The
present invention has accomplished these needs by creating a
medication package that does not require fine motor skill
functions, such as pinching and peeling. The present invention is
relatively easy to open when a user identifies the sequence
required to open the package, yet is extremely difficult to open in
any other fashion, thereby avoiding some of the inherent problems
of prior medication packages.
SUMMARY OF THE INVENTION
[0006] In its most general configuration, the present invention
advances the state of the art with a variety of new capabilities
and overcomes many of the shortcomings of prior devices in new and
novel ways. In its most general sense, the present invention
overcomes the shortcomings and limitations of the prior art in any
of a number of generally effective configurations. The instant
invention demonstrates such capabilities and overcomes many of the
shortcomings of prior methods in new and novel ways.
[0007] The child resistant medicament storage and distribution
package of the present invention is designed for housing a
medicament regardless of shape or size. The package includes a
blister portion and a blocking substrate, both sandwiched between a
dispensing substrate and a backing substrate. The arrangement of
these four primary components is unique and requires the execution
of a specific procedure to access the medicament. The required
procedure is easy for an adult to understand and accomplish, yet is
difficult for most children to understand and accomplish; thus
imparting a degree of child resistance previously unavailable,
while remaining senior friendly.
[0008] The blister portion contains a base layer and a blister
layer. The blister layer is formed to include an article receiving
blister designed for holding the medicament. The base layer may be
comprised of one or more separate layers of material, such as foil
and polyester or other suitable child resistant foil. Generally, at
least five percent, more preferably at ten percent and most
preferably at least fifteen percent of the surface area of a base
layer interior surface is joined to a blister layer interior
surface thereby sealing the medicament in the article receiving
blister. The area of the blister layer that is formed into the
article receiving blister or bubble is not joined to the base
layer.
[0009] The dispensing substrate is formed to have a dispensing
substrate blister receiver and a dispensing substrate initiation
region. The dispensing substrate blister receiver is configured to
cooperate with the blister portion such that a portion of the
article receiving blister extends through the dispensing substrate.
The dispensing substrate initiation region is an area that may be
used to transfer a force to the blocking substrate or as an area
that a portion of the blocking substrate may pass through.
[0010] The blocking substrate includes a gate having a gate free
edge and a gate retaining edge. The gate is generally rectangular
in shape with three of the sides being free from the surrounding
blocking substrate, and the forth side, referred to as the gate
retaining edge being connected to, or integral with, the
surrounding blocking substrate. The gate is positioned such that
initially a portion of the gate covers, or blocks, the article
receiving blister. As such, the gate must be moved, or slid, out of
the way in order to eject the medicament from the article receiving
blister.
[0011] The backing substrate is formed to have a backing substrate
initiation region and an article dispensing region. The backing
substrate initiation region may be identical to the dispensing
substrate initiation region, previously discussed. The article
dispensing region is configured to cooperate with the blister
portion. In other words, the article receiving blister and the
article dispensing region must generally align such that when the
medicament is ejected from the article receiving blister and the
gate is out of the way, that the medicament may pass through the
article dispensing region.
[0012] The assembly and orientation of the various elements of the
package imparts the desired functionality to achieve the
predetermined sequence of operation necessary to open the package.
To dispense the medicament from the package requires application of
a first force to a portion of the gate resulting in the gate free
edge sliding toward the gate retaining edge and past the article
dispensing region. Generally, the first force will be applied by a
tip of a human digit, most likely the thumb. The first force may be
applied from the backing substrate side of the package or may
alternatively be applied from the dispensing substrate side of the
package. The first force must only be significant enough to force a
portion of the gate out either the dispensing substrate initiation
region or the backing substrate initiation region. The gate may
incorporate a fold promoting characteristic that minimizes the
distance that the gate must be forced orthogonally away from the
package.
[0013] Thus, there is disclosed a medicament storage and
distribution package for housing a medicament, comprising:
[0014] (a) a blister portion having: [0015] (1) a base layer having
a base layer perimeter, a base layer exterior surface, and a base
layer interior surface; and, [0016] (2) a blister layer having a
blister layer perimeter, a blister layer exterior surface, a
blister layer interior surface, and including an article receiving
blister, having a blister perimeter, formed therein, wherein the
article receiving blister is designed for holding the medicament;
wherein [0017] (3) at least five percent of the surface area of the
base layer interior surface is joined to the blister layer interior
surface thereby sealing the medicament in the article receiving
blister;
[0018] (b) a dispensing substrate having a dispensing substrate
perimeter, a dispensing substrate interior surface, and a
dispensing substrate exterior surface, wherein the dispensing
substrate is formed to have: [0019] (1) a dispensing substrate
blister receiver configured to cooperate with the blister portion
such that a portion of the article receiving blister extends
through the dispensing substrate from the dispensing substrate
interior surface to the dispensing substrate exterior surface; and
[0020] (2) a dispensing substrate initiation region;
[0021] (c) a blocking substrate having a blocking substrate
perimeter, a blocking substrate front surface, and a blocking
substrate rear surface, wherein the blocking substrate includes a
gate having a gate perimeter including a gate free edge and a gate
retaining edge;
[0022] (d) a backing substrate having a backing substrate
perimeter, a backing substrate interior surface, and a backing
substrate exterior surface, wherein the backing substrate is formed
to have: [0023] (1) a backing substrate initiation region; and
[0024] (2) an article dispensing region having an article
dispensing region perimeter, wherein the article dispensing region
is configured to cooperate with the blister portion; and
[0025] (e) wherein the blister portion blister layer is adjacent to
the dispensing substrate interior surface, the blocking substrate
front surface is adjacent to the blister portion base layer, and
the backing substrate interior surface is adjacent to the blocking
substrate rear surface such that the dispensing substrate blister
receiver, the article receiving blister, and the article dispensing
region substantially align, and the gate is initially located
between the article dispensing region and the article receiving
blister to prevent unintentional dispensing of the medicament, such
that dispensing of the medicament requires application of a first
force to a portion of the gate resulting in the gate free edge
sliding toward the gate retaining edge and past the article
dispensing region such that application of a second force to the
article receiving blister forces the medicament to break through
the base layer, pass through an opening in the blocking substrate
created by the movement of the gate, and out the article dispensing
region.
[0026] There is further disclosed a medicament storage and
distribution package for housing a medicament, comprising:
[0027] (a) a blister portion having: [0028] (1) a base layer having
a base layer perimeter, a base layer exterior surface, and a base
layer interior surface; [0029] (2) a blister layer having a blister
layer perimeter, a blister layer exterior surface, a blister layer
interior surface, and including an article receiving blister,
having a blister perimeter, formed therein, wherein the article
receiving blister is designed for holding the medicament; wherein
[0030] (3) at least five percent of the surface area of the base
layer interior surface is joined to the blister layer interior
surface thereby sealing the medicament in the article receiving
blister;
[0031] (b) a dispensing substrate having a dispensing substrate
perimeter, a dispensing substrate interior surface, and a
dispensing substrate exterior surface, wherein the dispensing
substrate is formed to have: [0032] (1) a dispensing substrate
blister receiver configured to cooperate with the blister portion
such that a portion of the article receiving blister extends
through the dispensing substrate from the dispensing substrate
interior surface to the dispensing substrate exterior surface; and
[0033] (2) a dispensing substrate initiation region, sized to
cooperate with the dimensions of a tip of a human finger, integral
to the dispensing substrate and having a dispensing substrate
initiation region perimeter with (a) a portion that is a dispensing
substrate initiation region retaining edge that secures the
dispensing substrate initiation region to the dispensing substrate
and serves as a line about which the dispensing substrate
initiation region may pivot, and (b) a portion that is a dispensing
substrate initiation region breakaway edge that initially secures
the dispensing substrate initiation region to the dispensing
substrate until acted upon by a force of a predetermined magnitude
that causes the breakaway edge to release from the remainder of the
dispensing substrate;
[0034] (c) a blocking substrate having a blocking substrate
perimeter, a blocking substrate front surface, and a blocking
substrate rear surface, wherein the blocking substrate includes a
gate having a gate perimeter including a gate free edge and a gate
retaining edge, wherein the gate has a fold promoting
characteristic that causes the gate to begin to fold about the fold
promoting characteristic when the gate is displaced out of the
plane of the package by the first force, thereby creating a pivot
projection that is easily pivoted about the gate retaining edge and
away from the article receiving blister drawing the gate free edge
past the article receiving blister to permit dispensing of the
medicament;
[0035] (d) a backing substrate having a backing substrate
perimeter, a backing substrate interior surface, and a backing
substrate exterior surface, wherein the backing substrate is formed
to have: [0036] (1) a backing substrate initiation region, sized to
cooperate with the dimensions of a tip of a human finger, integral
to the backing substrate and having a backing substrate initiation
region perimeter with (a) a portion that is a backing substrate
initiation region retaining edge that secures the backing substrate
initiation region to the backing substrate and serves as a line
about which the backing substrate initiation region may pivot, and
(b) a portion that is a backing substrate initiation region
breakaway edge that initially secures the backing substrate
initiation region to the backing substrate until acted upon by a
force of a predetermined magnitude causing the breakaway edge to
release from the remainder of the backing substrate; and [0037] (2)
an article dispensing region having an article dispensing region
perimeter, wherein the article dispensing region is configured to
cooperate with the blister portion and the article dispensing
region is an integral portion of the backing substrate having a
separation line located substantially on the article dispensing
region perimeter to selectively reducing the strength of the
backing substrate, thereby permitting the medicament to break a
portion of the article dispensing region free of the backing
substrate along the separation line when the medicament is exposed
to the second force, thereby permitting the medicament to pass
through the article dispensing region for distribution; and
[0038] (e) wherein the blister portion blister layer is adjacent to
the dispensing substrate interior surface, the blocking substrate
front surface is adjacent to the blister portion base layer, and
the backing substrate interior surface is adjacent to the blocking
substrate rear surface such that the dispensing substrate blister
receiver, the article receiving blister, and the article dispensing
region substantially align, and the gate is initially located
between the article dispensing region and the article receiving
blister to prevent unintentional dispensing of the medicament, such
that dispensing of the medicament requires application of a first
force to a portion of the gate resulting in the gate free edge
sliding toward the gate retaining edge and past the article
dispensing region such that application of a second force to the
article receiving blister forces the medicament to break through
the base layer, pass through an opening in the blocking substrate
created by the movement of the gate, and out the article dispensing
region.
[0039] Various objects and advantages of the present invention will
become apparent from the following detailed description when viewed
in conjunction with the accompanying drawings, which set forth
certain embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] Without limiting the scope of the present invention as
claimed below and referring now to the drawings and figures:
[0041] FIG. 1 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0042] FIG. 2 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present;
[0043] FIG. 3 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0044] FIG. 4 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0045] FIG. 5 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0046] FIG. 6 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0047] FIG. 7 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0048] FIG. 8 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0049] FIG. 9 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0050] FIG. 10 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0051] FIG. 11 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0052] FIG. 12 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention;
[0053] FIG. 13 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package taken alone section line 13-13 in FIG. 6, in accordance
with the present invention;
[0054] FIG. 14 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package of FIG. 13 illustrating the sequence of operation, in
accordance with the present invention;
[0055] FIG. 15 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package of FIG. 13 illustrating the sequence of operation, in
accordance with the present invention;
[0056] FIG. 16 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package of FIG. 13 illustrating the sequence of operation, in
accordance with the present invention;
[0057] FIG. 17 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package of FIG. 13 illustrating the sequence of operation, in
accordance with the present invention;
[0058] FIG. 18 is a perspective view of an embodiment of the child
resistant senior friendly medicament storage and distribution
package in accordance with the present invention; and
[0059] FIG. 19 is a cross sectional view of an embodiment of the
child resistant senior friendly medicament storage and distribution
package of FIG. 13 illustrating the sequence of operation, in
accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0060] The child resistant blister medicament storage and
distribution package of the instant invention enables a significant
advance in the state of the art. The preferred embodiments of the
apparatus accomplish this by new and novel arrangements of elements
that are configured in unique and novel ways and which demonstrate
previously unavailable but preferred and desirable capabilities.
The detailed description set forth below in connection with the
drawings is intended merely as a description of the presently
preferred embodiments of the invention, and is not intended to
represent the only form in which the present invention may be
constructed or utilized. The description sets forth the designs,
functions, means, and methods of implementing the invention in
connection with the illustrated embodiments. It is to be
understood, however, that the same or equivalent functions and
features may be accomplished by different embodiments that are also
intended to be encompassed within the spirit and scope of the
invention.
[0061] From the figures, the child resistant medicament storage and
distribution package (10) of the present invention is designed for
housing a medicament (M) regardless of form, including, but not
limited to, round pills, oval pills, oblong capsules, caplets, etc.
As seen in FIG. 1, the package (10) includes a blister portion
(100), a dispensing substrate (200), a blocking substrate (300),
and a backing substrate (400). These four primary components are
assembled in a unique way that requires the execution of a specific
procedure to access the medicament (M), thereby imparting a degree
of child resistance previously unavailable, while remaining senior
friendly. The characteristics of the four primary components will
be briefly described so that the sequence of operation may be
explained.
[0062] First, the blister portion (100) contains a base layer (110)
and a blister layer (150). The base layer (110) has a base layer
perimeter (120), a base layer exterior surface (130), and a base
layer interior surface (140), labeled in FIGS. 1 and 14. Similarly,
the blister layer (150) has a blister layer perimeter (160), a
blister layer exterior surface (170), and a blister layer interior
surface (180), also labeled in FIGS. 1 and 15. The blister layer
(150) is formed to include an article receiving blister (190)
having a blister perimeter (196), best illustrated in FIG. 6. The
article receiving blister (190) is formed with a sidewall (192) and
an endwall (194) and is designed for holding the medicament (M),
illustrated in FIG. 16.
[0063] The blister layer (150) is preferably made of pharmaceutical
grade PVC or other thermoplastic material, such as plastic,
polypropylene, polyethylene, styrene, cold-formed foil, or other
suitable materials for packaging. The article receiving blister
(190) may be formed by a thermoforming process in which the blister
layer (150) material is stretched into a cavity with a vacuum
technique to form the blister portion. In a preferred embodiment, a
sheet of suitable material for the blister layer (150) is exposed
to heating elements for a pre-determined time. This sheet is then
trapped in a forming station where it is subjected to both vacuum
and pressure. During this process, the material may also be
mechanically assisted into the blister cavity via a matched metal
plug to form the article receiving blister (190). In another
embodiment, the article receiving blister (190) may be formed by
using cold-formed foil and cold-form packaging processes. As used
herein, "blister package" includes medication packages made with
cold-formed foil and using cold-form packaging processes. The base
layer (110) may be comprised of one or more separate layers of
material, such as foil and polyester or other suitable foils. The
base layer (110) is typically comprised of multiple layers, but it
could be made of any material.
[0064] Referring again to FIGS. 13-17, at least five percent, more
preferably at least 10 percent, of the surface area of the base
layer interior surface (130) is joined to the blister layer
interior surface (180) thereby sealing the medicament (M) in the
article receiving blister (190) up to 90 percent of the surface of
the base layer can be joined to the blister layer interior surface.
The blister layer (150) may be joined to the base layer (110) by
heat sealing, adhesive such as heat-activated adhesive that has
been pre-applied to the base layer (110) or solvent adhesive, radio
frequency or sonic seal, or by other suitable means. The area of
the blister layer (150) that is formed into the article receiving
blister (190) is not joined to the base layer (100). The blister
layer perimeter (160) generally corresponds to the base layer
perimeter (120).
[0065] Referring again to FIGS. 1-6, secondly, the dispensing
substrate (200) has a dispensing substrate perimeter (201), a
dispensing substrate interior surface (210), and a dispensing
substrate exterior surface (220). The dispensing substrate (200) is
formed to have a dispensing substrate blister receiver (230) and a
dispensing substrate initiation region (240). The dispensing
substrate blister receiver (230) is configured to cooperate with
the blister portion (100) such that a portion of the article
receiving blister (190) extends through the dispensing substrate
(200) from the dispensing substrate interior surface (210) to the
dispensing substrate exterior surface (220). This is illustrated
best in FIG. 2 where the blister portion (100) is shown, with the
article receiving blisters (190) pointing downward, as it is
brought into its installation position wherein the article
receiving blisters (190) are lowered into the dispensing substrate
blister receivers (230). The remainder of the assembly process is
illustrated in FIGS. 3-5, concluding with FIG. 6 illustrating the
article receiving blisters (190) projecting through the dispensing
substrate blister receivers (230).
[0066] The dispensing substrate initiation region (240) will be
discussed in greater detail later, however, for now initiation
region (240) need only be thought of as an area that may be used to
transfer a force to the blocking substrate (300) or as an area that
a portion of the blocking substrate (300) may pass through. The
dispensing substrate initiation region (240) may (a) simply be a
void formed in the dispensing substrate (200) thereby allowing
access to the blocking substrate (300), (b) a flap that rotates
away from the dispensing substrate exterior surface (220), (c) a
flap similar to that of (b) but including a means for attaching the
flap to the dispensing substrate (200) until a predetermined force
is exerted that causes the flap to break-away from the dispensing
substrate (200), or (d) a punch-out region that is attached to the
dispensing substrate (200), shielding the blocking substrate (300),
until acted upon by a predetermined force that punches-out the
region (240).
[0067] Thirdly, the blocking substrate (300) has a blocking
substrate perimeter (301), a blocking substrate interior front
surface (310), and a blocking substrate rear surface (320). As seen
in FIG. 3, the blocking substrate (300) includes a gate (340)
having a gate perimeter (342) including a gate free edge (343) and
a gate retaining edge (348). The gate (340) is generally
rectangular in shape with three of the sides being free from the
surrounding blocking substrate (300), and the forth side, referred
to as the gate retaining edge (348) being connected to, or integral
with, the surrounding blocking substrate (300). In addition to the
gate free edge (343), the other two free sides include the
sinistral edge (344) and the dextral edge (345), shown in FIG. 4.
The gate (340) is positioned such that initially a portion of the
gate (340) covers, or blocks, the article receiving blister (190).
As such, the gate (340) must be moved, or slid, out of the way in
order to eject the medicament (M) from the article receiving
blister (190). The functioning of the gate (340) will be described
later in greater detail.
[0068] The blocking substrate (300) may be a unitary piece of
material or it may be formed from the same piece of material as the
dispensing substrate (200), as seen in FIGS. 1-5. In one particular
embodiment, the blocking substrate (300) is comprised of a material
and thickness that cannot be readily torn, ruptured, or otherwise
compromised by a human finger pushing on the medicament (M) in the
article receiving blister (190). The material may be paper, or
other fiber product, plastic, foil, or composite.
[0069] Fourth, with continued reference to FIGS. 1-6, the package
(10) includes a backing substrate (400) having a backing substrate
perimeter (401), a backing substrate interior surface (410), and a
backing substrate exterior surface (420), labeled in FIG. 8 only.
The backing substrate (400) is formed to have a backing substrate
initiation region (430) and an article dispensing region (440). The
backing substrate initiation region (430) may be identical to the
dispensing substrate initiation region (240), previously discussed.
As with the dispensing substrate initiation region (240), the
backing substrate initiation region will be discussed in greater
detail later herein, and for now need only be thought of as an area
that may be used to transfer a force to the blocking substrate
(300) or as an area that a portion of the blocking substrate (300)
may pass through. The backing substrate initiation region (430) may
(a) simply be a void formed in the backing substrate (400) thereby
allowing access to the blocking substrate (300), (b) a flap that
rotates away from the backing substrate exterior surface (420), (c)
a flap similar to that of (b) but including a means for attaching
the flap to the backing substrate (400) until a predetermined force
is exerted that causes the flap to break-away from the backing
substrate (400), or (d) a punch-out region that is attached to the
backing substrate (400), shielding the blocking substrate, until
acted upon by a predetermined force that punches-out the region
(430).
[0070] The article dispensing region (440) has an article
dispensing region perimeter (442) and is configured to cooperate
with the blister portion (100), as seen in FIG. 3. In other words,
the article receiving blister (190) and the article dispensing
region (440) must generally align such that when the medicament (M)
is ejected from the article receiving blister (190), and the gate
(340) is out of the way, the medicament (M) may pass through the
article dispensing region (440). In one embodiment, seen in FIGS.
18 and 19, the backing substrate article dispensing region (440)
defines a void formed in the backing substrate (400) sized to
cooperate with the medicament (M) so that the medicament (M) may
pass through the article dispensing region (440) for
distribution.
[0071] Alternatively, the backing substrate article dispensing
region (440) may be an integral portion of the backing substrate
(400) having a separation line (444), seen in FIG. 5, selectively
reducing the strength of the backing substrate (400), thereby
permitting the medicament (M) to break a portion of the article
dispensing region (440) free of the backing substrate (400) along
the separation line (444) when the medicament (M) is exposed to the
second force, thus permitting the medicament (M) to pass through
the article dispensing region (440) for distribution. In a further
embodiment, the separation line (444) is located substantially on
the article dispensing region perimeter (442). The separation line
(444) need not be one continuous separation line (444) and may
include one or more die cuts, perforations, indentations, score
lines, and weakened fracture lines. As with the blocking substrate
(300), in one particular embodiment the backing substrate (400) is
comprised of a material and thickness that cannot be readily torn,
ruptured, or otherwise compromised by a human finger pushing on the
medicament (M) in the article receiving blister (190). The material
may be paper, or other fiber product, plastic, foil, or
composite.
[0072] The assembly and orientation of the various elements of the
package (10) imparts the desired functionality to achieve the
predetermined sequence of operation necessary to open the package
(10). The general assembly process is illustrated in FIGS. 1-6.
Although the figures illustrate the dispensing substrate (200), the
blocking substrate (300), and the backing substrate (400) as being
formed from a single continuous substrate that is folded multiple
times, one with skill in the art will appreciate that each of these
components may be separate and distinct elements that are joined
together to create the package (10). However, the continuous
substrate embodiment illustrated in the figures is preferred for
its high-speed formation and assembly characteristics. Such
characteristics include having predetermined fold locations between
the various substrates (200, 300, 400) so that the gate (340), the
article dispensing region (440), and the initiation regions (240,
430) are consistently and precisely placed in relation with one
another to cooperate to achieve the desired sequence of
operation.
[0073] The blister portion (100) is located between the dispensing
substrate (200) and the blocking substrate (300). In fact, the
blister portion blister layer (150) is adjacent to the dispensing
substrate interior surface (210) and the blocking substrate front
surface (310) is adjacent to the blister portion base layer (110).
As seen in FIG. 2, the blister portion (100) is brought into
proximity to the dispensing substrate (200) and placed so that the
article receiving blisters (190) mate with the dispensing substrate
blister receivers (230).
[0074] Once the blister portion (100) is in place, the blocking
substrate (300) is brought into contact with the blister portion
(100). In the embodiment of FIGS. 3 and 4, the blocking substrate
(300) is merely rotated into the correct position against the
blister portion (100). As seen in FIG. 4, each gate (340) covers a
portion of the base layer (110) that is closing an article
receiving blister (190). The gate (340) is initially located
between the article dispensing region (440) and the article
receiving blister (190) to prevent unintentional dispensing of the
medicament (M). Additionally, the width of the gate (340) is less
than the width of the dispensing substrate initiation region (240)
so that a portion of the gate (340) may be fed through the
initiation region (240), as will be discussed later.
[0075] Then, with the blocking substrate (300) in place, the
backing substrate (400) is brought into position to essentially
close the package (10). In the embodiment of FIGS. 1-6, this
positioning merely involved folding the backing substrate (400) to
cover the blocking substrate (300) and the blister portion (100).
As seen in the figures, the dispensing substrate perimeter (201)
and the backing substrate perimeter (401) will generally be
identical with the dispensing substrate initiation regions (240)
substantially symmetrical to the backing substrate initiation
region (430) and the dispensing substrate blister receivers (230)
substantially symmetrical to the article dispensing regions (440).
The various elements may be individually joined together via
adhesive or other material joining technique; however, in the
embodiment of FIGS. 1-6 the dispensing substrate (200) is generally
only joined to the backing substrate (400). In this embodiment, the
blister portion (100) is held in place by the dispensing substrate
blister receivers (230) and the action of the backing substrate
(400) ensuring that the article receiving blisters (190) remain in
the dispensing substrate blister receivers (230). Further, in this
embodiment the blocking substrate (300) is held in position by
virtue of its connection to the dispensing substrate (200). The
child resistance is further increased by the fact that the
previously disclosed method of joining the backing substrate (400)
to the dispensing substrate (200) ensures that peeling, or
separation, of the substrates (200, 400) from one another by human
fingers is extremely difficult, if not impossible. In one
embodiment of assembly, the blister is sealed between parts (300)
and (200). The area (310) seals to the blister unit base layer
(lidding top) and also to (210). The initiation region on (200) is
also sealed to the gate between the area from (348) to (350). Next
(400) is sealed to (320) and (210). The initiation region on (400)
is also sealed to the gate between the area from (348) to (350) on
the opposite side of (300). With this assembly, the gate becomes
attached to the two initiation regions and the blister unit becomes
well protected from access from the outer edges of the package.
[0076] The user could also remove or tear out the gate (340)
instead of holding it flat after being hinged. The gate retaining
edge (348) can be perforated so that it can be torn out from the
package along with the two initiation regions (240, 430).
[0077] It should be noted that although the figures of the present
application illustrate package (10) embodiments having six article
receiving blisters (190), and therefore six gates (340), six
article dispensing regions (440), six dispensing substrate
initiation regions (240), and six backing substrate initiation
regions (430), the present invention need only incorporate one of
each of the previously listed elements, yet may incorporate
hundreds of such elements.
[0078] Now, to dispense the medicament (M) from the package (10)
requires application of a first force to a portion of the gate
(340) resulting in the gate free edge (343) sliding toward the gate
retaining edge (348) and past the article dispensing region (440),
as seen in FIGS. 7, 8, 13, and 16. Generally, the first force will
be applied by a tip of a human digit, most likely the thumb. The
first force may be applied from the backing substrate (400) side of
the package (10), as seen in FIG. 8, or may alternatively be
applied from the dispensing substrate (200) side of the package
(10). The first force must only be significant enough to displace a
portion of the gate (340) through either the dispensing substrate
initiation region (240) or the backing substrate initiation region
(430), when the regions (240, 430) are merely voids in the
substrates (200, 400), causing the desired movement of the gate
free edge (343). However, if as previously disclosed, either, or
both, regions (240, 430) include a flap that may, or may not, be
attached to the surrounding substrate (200, 400) then the first
force must be greater in magnitude to displace, or break-free, the
flap.
[0079] The initiation regions (240, 430) and the gate (340) may be
designed such that a user simply keeps displacing a portion of the
gate (340) away from the package until the gate free edge (343)
moves the requisite distance so as not to block the path of the
medicament (M), or the gate (340) may incorporate a fold promoting
characteristic (350) that minimizes the distance that the gate
(340) must be forced orthogonally away from the package (10). In
fact, the fold promoting characteristic (350) is generally a
feature applied to the gate (340) that causes it to fold in a
predetermined location and fashion as the first force is applied.
In particular, as seen in FIGS. 8 and 15, one embodiment of the
fold promoting characteristic (350) causes the gate (340) to fold
as soon as it is displaced out of the plane of the package (10).
This folding action creates a pivot projection (352) that a user
may then pivot away from the associated article receiving blister
(190), thereby resulting in the desired movement of the gate free
edge (343), as seen in FIGS. 9, 10, and 16. This embodiment is
particular effective because it is easy for an adult to apply the
first force that displaces the gate (340) and creates the pivot
projection (352) that is then simply pivoted by pushing the
projection toward the package (10), thus not requiring fine motor
skills.
[0080] Now, with the gate (340) no longer blocking the path of the
medicament (M) from the article receiving blister (190) to the
article dispensing region (440), application of a second force to
the article receiving blister (190) forces the medicament (M) to
break through the base layer (110), pass through an opening in the
blocking substrate (300) created by the movement of the gate (340),
and out the article dispensing region (440), as seen in FIGS. 12,
16, and 17.
[0081] The fold promoting characteristic (350) is best seen in
FIGS. 3 and 13. The fold promoting characteristic (350) need not be
one continuous line and may include one or more die cuts,
perforations, indentations, score lines, and weakened fracture
lines. The fold promoting characteristic (350) is generally aligned
on the gate (340) so that it lies substantially in-line with the
portion of the dispensing substrate initiation region breakage edge
(243) farthest from the dispensing substrate initiation region
retaining edge (244), and lies substantially in-line with the
portion of the backing substrate initiation region breakage edge
(433) farthest from the backing substrate initiation region
retaining edge (434), as seen in FIGS. 13 and 14.
[0082] The important attributes afforded to the package (10) by the
gate (340) are best illustrated in FIGS. 13-17. First, FIG. 13
illustrates a cross sectional view of the package (10) prior to any
manipulation by the user. Secondly, FIG. 14 illustrates the
breakage of the dispensing substrate initiation region (240) away
from the dispensing substrate (200) and the backing substrate
initiation region (430) away from the backing substrate (400), as
well as the initial displacement of the gate (430) and fold
formation along the fold promoting characteristic (350). Next, FIG.
15 illustrates further movement of the blocking substrate gate free
edge (343) such that it is only partially blocking the medicament
(M). In this particular embodiment the position of the blocking
substrate gate free edge (343) remains blocking the medicament (M)
even after the first force has displaced the gate (340)
orthogonally from the package (10) as much as possible. Therefore,
the user must then rotate, or pivot, the gate (340) and initiation
regions (240, 430), when present, as seen in FIG. 16 to completely
draw the gate free edge (343) past the medicament (M), and
therefore the article dispensing region (440), so that application
of the second force on the article receiving blister (190) causes
the medicament (M) to break free of the base layer (110) and to
exit, or break free of, the article dispensing region (440), as
seen in FIG. 17.
[0083] As previously discussed, the dispensing substrate initiation
region (240) may simply define a void formed in the dispensing
substrate (200), as seen in FIGS. 18 and 19, sized to cooperate
with the gate (340) and the average size tip of a human finger such
that application of the first force by a human finger results in a
portion of the gate (340) extending through the dispensing
substrate initiation region (240). Similarly, the backing substrate
initiation region (430) may simply define a void formed in the
backing substrate (400) sized to cooperate with the gate (340) and
the average size tip of a human finger such that application of the
first force by a human finger results in a portion of the gate
(340) extending through the backing substrate initiation region
(430). However, in such embodiments the gate (340) is more apt to
be accidentally moved than embodiments that incorporate covers that
initially shield the gate (340) from access. In yet another
preferred embodiment, the dispensing substrate initiation region
(240) and the backing substrate initiation region (430) are between
approximately 0.12 square inches and approximately 0.5 square
inches to correspond the a wide range of human fingertip sizes.
[0084] In alternative embodiments seen in FIGS. 1-17, the
initiation regions (240, 430) are integral to the surrounding
substrate (200, 400), thereby shielding the gate (340) from
unintentional contact and increasing the child resistance of the
package (10). In such embodiments, the first force is transferred
to the gate (340) through the initiation regions (240, 430). In
this embodiment, seen in FIG. 7, the dispensing substrate
initiation region (240) has a dispensing substrate initiation
region retaining edge (244) that connects the initiation region
(240) to the surrounding dispensing substrate (200), and serves as
a line about which the initiation region (240) rotates upon
application of the first force. Similarly, as seen in FIGS. 4, 14,
and 15, the backing substrate initiation region (430) has a backing
substrate initiation region retaining edge (434) that connects the
initiation region (430) to the surrounding backing substrate (400),
and serves as a line about which the initiation region (430)
rotates upon application of the first force. In still further
embodiments, the child resistance is even more improved by ensuring
that the entire perimeters (242, 432) of the regions (240, 430) are
at least intermittently attached to the adjacent substrate (240,
430). In such embodiments, the perimeters (242, 432) include not
only the retaining edges (244, 434), but also breakaway edges (243,
433), as seen in FIGS. 4 and 7, that selectively reduce the
strength of the corresponding substrate (200, 400). The breakaway
edges (243, 433) increase the magnitude of the first force that is
required to displace the gate (340) because the corresponding
regions (240, 430) must first be broken free of the adjacent
substrate (200, 400) along the breakaway edges (243, 433). The
breakaway edges (243, 433) need not be one continuous line and may
include one or more die cuts, perforations, indentations, score
lines, weakened fracture lines, and the like. As with the blocking
substrate (300) and the backing substrate (400), in one particular
embodiment the dispensing substrate (200) is comprised of a
material and thickness that cannot be readily torn, ruptured, or
otherwise compromised by a human finger. The material may be paper,
or other fiber product, plastic, foil, or composite. The package
(10) of the present invention may further include a cover substrate
(500), seen in FIG. 7, for protection of the article receiving
blister (190).
[0085] Numerous alterations, modifications, and variations of the
preferred embodiments disclosed herein will be apparent to those
skilled in the art and they are all anticipated and contemplated to
be within the spirit and scope of the instant invention. For
example, although specific embodiments have been described in
detail, those with skill in the art will understand that the
preceding embodiments and variations can be modified to incorporate
various types of substitute and or additional or alternative
materials, relative arrangement of elements, and dimensional
configurations. Accordingly, even though only few variations of the
present invention are described herein, it is to be understood that
the practice of such additional modifications and variations and
the equivalents thereof, are within the spirit and scope of the
invention as defined in the following claims.
INDUSTRIAL APPLICABILITY
[0086] The child resistant medicament storage and distribution
package answers a long felt need for a novel package that is both
child resistant and senior-friendly. The package is for use with
small or large medicaments of various shapes. The present invention
discloses a package that implements requiring the performance of
multiple steps before the medicament can be dispensed, thereby
avoiding some of the inherent problems of medication packages that
use peeling to be opened. The package of the present invention is
relatively easy for an adult to manipulate, but not easy for a
child to access the package.
* * * * *